Drugs List

Therapeutic Indications

Uses

Moderate to severe active rheumatoid arthritis-other regimens unsuitable

Treatment of moderate to severe active rheumatoid arthritis in adults who have responded inadequately to or are intolerant to one or more disease-modifying anti-rheumatic drugs (DMARDs).
Filgotinib can be used as monotherapy or in combination with methotrexate.

Contraindications

Absolute lymphocyte count below 0.5 x 10 to the power of 9/L
Children under 18 years
Haemoglobin concentration below 8g / dL
Neutrophil count below 1.0 x 10 to the power of 9 / L at baseline
Severe infection
Breastfeeding
Galactosaemia
Pregnancy
Renal impairment - creatinine clearance below 15ml/minute
Severe hepatic impairment
Tuberculosis

Precautions and Warnings

Females of childbearing potential
History of recurrent infection
Obesity
Patients over 75 years
Predisposition to infection
Predisposition to venous thromboembolism
Prolonged immobilisation
Surgery
Glucose-galactose malabsorption syndrome
History of tuberculosis
History of venous thromboembolism
Hyperlipidaemia
Hypertension
Lactose intolerance
Malignant neoplasm
Moderate renal impairment

Administration of live vaccines is not recommended
Before initiating screen all patients for viral hepatitis
Interrupt therapy if herpes zoster occurs
Advise patient dizziness may affect ability to drive or operate machinery
Avoid concurrent use of immunosuppressants
Before starting therapy ensure immunisations are up to date
Monitor patients for non-melanoma skin cancer prior to and during treatment
Prior to starting therapy screen for latent tuberculosis
Treatment to be initiated and supervised by a specialist
Contains lactose
Monitor for and manage hepatitis reactivation during treatment
Monitor patient for signs of serious infection
Monitor serum lipids 3 months after initiation
Monitor serum lipids in patients with hyperlipidaemia
Advise patient to seek med advice if signs/symptoms of tuberculosis develop
Immunosuppressive drugs may increase risk of malignancy
Interrupt if haemoglobin falls below 8 g/dL
Interrupt if lymphocyte count less than 0.5 x 10 to the power of 9/L
Interrupt therapy if neutrophil count <1.0x10 to the power 9/L
Interrupt treatment if severe infection develops
Discontinue if symptoms of deep vein thrombosis occur
Discontinue if symptoms of pulmonary embolism occur
Male: May cause infertility
Female: Contraception required during and for 1 week after treatment

Pregnancy and Lactation

Pregnancy

Filgotinib is contraindicated during pregnancy.

The manufacturer advises that filgotinib may cause foetal harm and should not be used during pregnancy. Animal studies have shown reproductive toxicity.

Lactation

Filgotinib is contraindicated during breastfeeding.

The manufacturer advises that filgotinib should not be used during breastfeeding as it is unknown whether it is excreted in human milk. A risk to newborns/infants cannot be excluded.

Side Effects

Creatine phosphokinase increased
Deep vein thrombosis (DVT)
Dizziness
Herpes zoster
Hypercholesterolaemia
Nausea
Neutropenia
Pneumonia
Pulmonary embolism
Upper respiratory tract infection
Urinary tract infections

Presentation

Oral formulations of filgotinib.

Drugs List

Therapeutic Indications

Uses

Moderate to severe active rheumatoid arthritis-other regimens unsuitable

Treatment of moderate to severe active rheumatoid arthritis in adults who have responded inadequately to or are intolerant to one or more disease-modifying anti-rheumatic drugs (DMARDs).
Filgotinib can be used as monotherapy or in combination with methotrexate.

Dosage

Adults

Elderly

Patients with Renal Impairment

Contraindications

Absolute lymphocyte count below 0.5 x 10 to the power of 9/L
Children under 18 years
Haemoglobin concentration below 8g / dL
Neutrophil count below 1.0 x 10 to the power of 9 / L at baseline
Severe infection
Breastfeeding
Galactosaemia
Pregnancy
Renal impairment - creatinine clearance below 15ml/minute
Severe hepatic impairment
Tuberculosis

Precautions and Warnings

Females of childbearing potential
History of recurrent infection
Obesity
Patients over 75 years
Predisposition to infection
Predisposition to venous thromboembolism
Prolonged immobilisation
Surgery
Glucose-galactose malabsorption syndrome
History of tuberculosis
History of venous thromboembolism
Hyperlipidaemia
Hypertension
Lactose intolerance
Malignant neoplasm
Moderate renal impairment

Administration of live vaccines is not recommended
Before initiating screen all patients for viral hepatitis
Interrupt therapy if herpes zoster occurs
Advise patient dizziness may affect ability to drive or operate machinery
Avoid concurrent use of immunosuppressants
Before starting therapy ensure immunisations are up to date
Monitor patients for non-melanoma skin cancer prior to and during treatment
Prior to starting therapy screen for latent tuberculosis
Treatment to be initiated and supervised by a specialist
Contains lactose
Monitor for and manage hepatitis reactivation during treatment
Monitor patient for signs of serious infection
Monitor serum lipids 3 months after initiation
Monitor serum lipids in patients with hyperlipidaemia
Advise patient to seek med advice if signs/symptoms of tuberculosis develop
Immunosuppressive drugs may increase risk of malignancy
Interrupt if haemoglobin falls below 8 g/dL
Interrupt if lymphocyte count less than 0.5 x 10 to the power of 9/L
Interrupt therapy if neutrophil count <1.0x10 to the power 9/L
Interrupt treatment if severe infection develops
Discontinue if symptoms of deep vein thrombosis occur
Discontinue if symptoms of pulmonary embolism occur
Male: May cause infertility
Female: Contraception required during and for 1 week after treatment

Pregnancy and Lactation

Pregnancy

Filgotinib is contraindicated during pregnancy.

The manufacturer advises that filgotinib may cause foetal harm and should not be used during pregnancy. Animal studies have shown reproductive toxicity.

Lactation

Filgotinib is contraindicated during breastfeeding.

The manufacturer advises that filgotinib should not be used during breastfeeding as it is unknown whether it is excreted in human milk. A risk to newborns/infants cannot be excluded.

Side Effects

Creatine phosphokinase increased
Deep vein thrombosis (DVT)
Dizziness
Herpes zoster
Hypercholesterolaemia
Nausea
Neutropenia
Pneumonia
Pulmonary embolism
Upper respiratory tract infection
Urinary tract infections

Overdosage

It is strongly recommended that the UK National Poisons Information Service be consulted on cases of suspected or actual overdose where there is doubt over the degree of risk or about appropriate management.

The following number will direct the caller to the relevant local centre (0844) 892 0111

Information may be obtained if you have access to ToxBase the primary clinical toxicology database of the National Poisons Information Service. This is available via password on the internet ( www.toxbase.org ) or if this is unavailable at the backup site ( www.toxbasebackup.org ).

Further Information

Last Full Review Date: January 2022

Reference Sources

Summary of Product Characteristics: Jyseleca 100mg film-coated tablets. Gilead Sciences Ltd. Revised December 2021.
Summary of Product Characteristic: Jyseleca 200mg film-coated tablets. Gilead Sciences Ltd. Revised December 2021.